The primary objective of the study is to explore the efficacy and safety of ATryn® (antithrombin alfa) for the treatment of disseminated intravascular coagulation (DIC) associated with severe sepsis, when administered by continuous intravenous (IV) infusion over five days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Patients Alive on Day 28, Having Had an Improvement in the DIC Score (Overt or Non-overt) by at Least 2 Points Between Baseline and Day 6 and Having Had no Worsening of the SOFA Score Between Baseline and Day 6.
Disseminated Intravascular Coagulation (DIC) ranges from 0 to 8 points, the higher the score the worse coagulation/outcome. Sepsis-related Organ Failure Assessment (SOFA) is a composite score of scores for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each system is scored from 0 to 4 with a higher score given for worse organ function. The scores are then added together to give a total range from 0 to 24 with a higher score representing a worse outcome.
Time frame: Day 28
Mortality at Day 28
Time frame: Day 28
Mortality at Day 90
Time frame: Day 90
Change From Baseline to Day 6 in SOFA Score Among Survivors on Day 6
Sepsis-related Organ Failure Assessment (SOFA) is a composite score of scores for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each system is scored from 0 to 4 with a higher score given for worse organ function. The scores are then added together to give a total range from 0 to 24 with a higher score representing a worse outcome.
Time frame: Baseline to Day 6
Change From Baseline to Day 6 in DIC Score Among Survivors on Day 6
Disseminated Intravascular Coagulation (DIC) ranges from 0 to 8 points, the higher the score the worse coagulation/outcome
Time frame: Baseline to Day 6
Days Alive and Out of ICU Day 28
Days alive and out of ICU at day 28 for all patients
Time frame: Baseline to Day 28
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Days Alive and Out of Hospital Day 28
Days alive and out of Hospital at day 28 for all patients
Time frame: Baseline to Day 28
Days Alive and Free of Inotrope/Vasopressor Support Day 28
Days alive and free of inotrope/vasopressor at day 28 for all patients
Time frame: Baseline to Day 28
Days Alive and Off Ventilator Day 28
Days alive and free of mechanical ventilation at day 28 for all patients
Time frame: Baseline to Day 28
Days Alive and Free of Need for Renal Replacement Therapy Day 28
Days alive and out of renal replacement therapy at day 28 for all patients
Time frame: Baseline to Day 28
Change From Baseline to Day 6 in Inflammation Marker IL-6
Time frame: Baseline to Day 6
Change From Baseline to Day 6 in Inflammation Marker Procalcitonin
Time frame: Baseline to Day 6